Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Reported: May 29, 2024 Initiated: April 22, 2024 #D-0502-2024
Product Description
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Reason for Recall
Failed Release Testing: Out of specification for particulate matter test.
Details
- Recalling Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Units Affected
- 35,069 bottles
- Distribution
- TX, PA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90. Recalled by SUN PHARMACEUTICAL INDUSTRIES INC. Units affected: 35,069 bottles.
Why was this product recalled? ▼
Failed Release Testing: Out of specification for particulate matter test.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 29, 2024. Severity: Low. Recall number: D-0502-2024.
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